Hiring: Quality Engineer III
Location: Santa Clara, CA (100% Onsite)
Duration: 12-month contract
Shift: Monday – Friday | 8:00 AM – 5:00 PM
Type: W2 Contract
Industry: Medical Devices
We are actively hiring a Quality Engineer III for a leading Medical Device company. This is an excellent opportunity for experienced Quality Engineers with strong expertise in Quality Systems, CAPA, Compliance, and Audit Support.
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Key Responsibilities:
• Support Quality Systems & Compliance activities
• Investigate and manage CAPAs and non-conformances
• Support internal/external audits and audit preparedness
• Process change orders and quality system updates
• Manage KPI dashboards and compliance metrics
• Drive process improvements and corrective actions
• Collaborate with Regulatory Affairs and cross-functional teams
• Manage multiple quality/compliance projects independently
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Requirements:
• Bachelor's degree in Engineering, Life Sciences, or related field preferred
• 5–7 years of Quality Engineering experience in the Medical Device industry
• Strong experience in Quality Systems & Compliance
• Hands-on experience with CAPA investigations and management
• Experience supporting internal/external audits
• Knowledge of Change Management and Process Improvement
• Strong analytical, troubleshooting, and communication skills
• Knowledge of FDA regulations, ISO 13485, and EU MDR is preferred
• Experience with Power BI, Windchill, and KPI dashboards is a plus
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